Abstract

Background

Methods

Patients in PALOMA -3 study (NCT 01942135; Turner et al. NEJM 2016) were randomized to palbociclib plus fulvestrant (n= 347) or placebo plus fulvestrant (n= 174). Patient-reported outcomes were assessed at baseline, on day 1 of each cycle until cycle 4 and every alternate cycle from cycle 6 until end of treatment using EQ-5D, a standardized measure of health status that consists of a descriptive system comprising 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression rated at 3 levels (no, some, or extreme problems) and a single index score for health status (range 0 [dead] to 1 [full health]) calculated using a standard algorithm. In addition, a visual analog scale (VAS) measured self-rated health status from ‘0’ (worst imaginable) to ‘100’ (best imaginable). Repeated measures mixed-effects analyses were performed to compare overall index and VAS scores between treatments, controlling for baseline.

Results

Completion rates at baseline were ≥85% in each group. The mean (SD) scores at baseline were comparable between palbociclib plus fulvestrant and fulvestrant alone for the VAS (72.9 [17.22] vs 70.3 [19.87]) and the EQ-5D index scores (0.73 [0.23]) vs (0.71 [0.23]). General health status assessed by VAS was found to be maintained from baseline and no significant difference in overall EQ-5D VAS scores was observed between the treatment arms. The proportion of patients reporting the presence of a problem at baseline was similar for palbociclib plus fulvestrant and fulvestrant, respectively: mobility (28% vs 32%), self-care (9% vs 9%), usual activities (38% vs 45%), pain (67% vs 67%), and anxiety/depression (52% vs 61%). The overall mean EQ-5D index scores on treatment was significantly greater (p

Conclusions

Addition of palbociclib to fulvestrant was associated with significantly higher on treatment EQ-5D index scores compared to fulvestrant alone.